Fatigue Syndrome, Chronic, Cardiovascular Diseases
Conditions
Brief summary
Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) is a disease characterized by persistent and unexplained fatigue associated with diffuse pain, sleep disorders, neurocognitive and autonomic symptoms, musculoskeletal manifestations and digestive symptoms. A central feature of this disease is post-exertional symptom exacerbation, also referred to as post-exertional malaise, defined as the worsening or the appearance of symptoms after physical or mental exertion, sometimes even minimal. Several studies have described post-exertional malaise in populations of patients with ME/CFS following a standardized exercise test performed over one or two consecutive days. These studies confirmed the presence of post-exertional malaise in ME/CFS patients compared with healthy controls or patients with multiple sclerosis. However, no data are available evaluating the impact of an exercise test on symptoms in patients referred to cardiology for this examination. Patients with cardiac diseases may also present symptoms such as fatigue, dyspnea or exercise intolerance. This study aims to compare post-exertional symptoms in two populations: patients with ME/CFS and patients with cardiac diseases undergoing an exercise test as part of routine clinical evaluation. The study also aims to measure variations in muscle oxyhemoglobin and deoxyhemoglobin concentrations before, during and after exercise using Near Infrared Spectroscopy (NIRS).
Interventions
OTHERExercise test on ergocycle
Participants will undergo a standardized exercise test performed on a cycle ergometer. Symptoms will be assessed using questionnaires before the test and during the 7 days following the exercise test.
Muscle oxygenation will be monitored using Near Infrared Spectroscopy (NIRS) before, during and after exercise
Sponsors
Hôpital Européen Marseille
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 18 years * For patients with Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS): Clinical diagnosis of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome according to the International Consensus Criteria (ICC) 2011. * For patients with cardiac diseases : patients referred for an exercise test in the cardiology department for one of the following indications: palpitations, hypertension, exertional dyspnea, chest pain, cornoray artery disease and presence of moderate to severe fatigue defined as a Numerical Rating Scale (NRS) \> 3/10 during the last 8 days and no diagnosis of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome. * Ability to use a computer or digital device required to complete online questionnaires. * Having given free and informed written consent
Exclusion criteria
* Pregnant or breastfeeding woman * Persons deprived of their liberty by a judicial or administrative decision. * Persons who are subject to a legal protection measure or who are unable to express their consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to onset of symptoms after completion of the exercise test on an ergocycle in both groups. | From immediately after the exercise test up to Day 7. | Type of symptoms reported by participants after the exercise test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms observed during the 7 days following the exercise test in both groups | From immediately after the exercise test up to Day 7. | Type of symptoms reported by participants after the exercise test. |
| Duration of symptoms after the exercise test in both groups. | From immediately after the exercise test up to Day 7. | Type of symptoms reported by participants after the exercise test. |
| Intensity of post-exercise symptoms measured in both groups. | From immediately after the exercise test up to Day 7. | Type of symptoms reported by participants after the exercise test. |
| Characterization of symptoms experienced before the exercise test in both groups. | Day 0 (prior to the exercise test). | Baseline characterization of symptoms using the DePaul Symptom Questionnaire (DSQ) completed by participants before the exercise test. |
| Variations in oxyhemoglobin and deoxyhemoglobin concentrations measured by Near Infrared Spectroscopy (NIRS) at the muscular level before, during and after exercise. | Before, during, and up to 10 minutes after the exercise test. | Measurement of changes in oxyhaemoglobin and deoxyhaemoglobin concentrations in muscle tissue using Near-Infrared Spectroscopy (NIRS). |
Countries
France
Contacts
CONTACTMyriam BENNANI
Outcome results
None listed